Secondary prevention of heart failure with a reduced ejection fraction Circulatory System Left ventricular failure
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 75 years 2. Stable heart failure with an ejection fraction between 20% and 40% 3. New York Heart Association (NYHA) functional class of heart failure between I and III, with optimal treatment at the maximum tolerated dose (including defibrillator or resynchronization therapy) 4. No major cardiovascular event, hospitalization, or cardiovascular intervention in the last 3 months prior to randomization without additional need for short-term (6 months) revascularization
Exclusion criteria
Exclusion criteria: 1. Inability to exercise 2. Atrial fibrillation with a ventricular response at rest >110 beats per min at rest 3. Appropriate shock of the defibrillator in the past 3 months 4. Patient dependent on the pacemaker 5. Uncontrolled diabetes 6. Insulin pump 7. Uncontrolled arterial hypertension, systolic blood pressure >160 mmHg 8. On hemodialysis 9. Left ventricular enlargement or septal enlargement (>18 mm) or any obstruction of the left ventricle 10. Right ventricular pressure >60 mmHg 11. Severe valve disease based on ultrasound diagnosis 12. Addiction to an illegal drug 13. Inability to read and understand the consent form 14. Any situation where the principal investigator perceives that the patient will not adhere to the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Effectiveness is measured with cardiovascular tests including echography and cardiopulmonary tests such as maximal oxygen uptake (VO2max) at baseline and 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Quality of life measured using the World Health Organization Quality of Life (WHOQOL) questionnaire at baseline and 3 months 2. Functional capacity measured using the 6-min walk test and the Timed Up and Go test at baseline and 3 months | — |
Countries
Canada